1. Field of the Invention
This invention relates generally to a method and device for alleviating erectile impotency, and especially to a surgically implantable pump device that may be implanted to facilitate injecting blood to inflate the corpus cavernosum of the penis. An implantable pump assembly includes a blood inlet artery connection, a blood receiving chamber, a non-return valve, a blood ejection elastic compression chamber and an outlet artery connection.
Briefly the invention discloses a pump assembly designed to be surgically connected to an internal artery to increase the influx of blood flow to the dorsal and deep arteries that feeds the penis. The pump assembly is to be implanted in the lower part of the abdomen in a way that will not prevent normal flow of the blood. Upon pressing the elastic enclosure of a compression chamber, a non-return valve closes and an influx of blood is injected to flow into the dorsal and deep arteries of the penis. Upon releasing of the compression chamber, the compression chamber springs back to its original shape, the non-return valve opens and the blood is drawn into the compression chamber. Repeated act of pressing and releasing the compression chamber result in forced injections of the blood influx into the penis organ that quickly cause erection. In addition to the normal blood flow to the penis, the pump draws blood from an internal pudendal artery and inject it into the than the dorsal and deep arteries of the penis. An increased flow of blood delivered to the penis will not restrict the normal flow at any time but provide an adequate influx of blood when needed. Upon conclusion of the sexual activity and withdrawal, the blood drains naturally through the dorsal vein and the penis returns to its normal flaccid condition.
2. Brief Description of the Background of the Art
Erectile Dysfunction (ED) is defined as the inability of a man to attain or sustain an erection sufficient for sexual intercourse or when a man has problems getting or maintaining an erection long enough for sex. It happens when not enough blood flows to the penis that can be persistent condition. ED isn't the same for all men; some men aren't able to get an erection at all, others can get one, but it's not hard enough for sex. Others get a hard erection but lose it before or during sex. ED is a medical condition due to several causes impairing blood flow to the penis, so in many cases erections will not improve without treatment.
Common treatments aim to increase blood flow into the penis to cause erection, these treatments include: Drugs, Needle injection therapy, self administered intrauethral therapy, use of vacuum devices and vascular surgery.
Drug treatments similar to Sildenafil (Viagra), Tadalafil (Cialis), and Vardenafil (Levitra) are prescribed by physicians to ED patients. These drugs enhance the effects of nitric oxide, a chemical messenger that relaxes smooth muscles in the penis. This increases the amount of blood and allows a natural sequence to occur for an erection in response to sexual simulation. It is known that these drugs can cause common side effects similar to headache, facial flushing, and upset stomach and less commonly, bulrush vision, blurred vision or sensitivity to light may occur. Physicians must administer and determine the dose for patients that have liver or kidney problems, taking prostate inhibitor, have high blood pressure or have previous history of heart attack, stroke or life-threatening heart rhythm.
In needle-injection therapy method, the patient uses a fine needle to inject a drug called Alprostadil (al-pros-tuh-dil) into the base or side of his penis. This generally produces an erection in five to 20 minutes that lasts about an hour. Because the injection goes directly into the spongy cylinders that fill with blood, alporstadil is an effective treatment for many men. Side effects may include bleeding from injection, prolonged erection and formation of fibrous tissue at the injection site. The cost per injection can be expensive. Other lesser expensive injection drugs include Papaverine and Phentlamine (Regitne).
The self-administered intraurethral therapy is known as Medicated Urethral System for Erection (MUSE). The patient uses a disposable applicator to insert a tiny suppository about half the size of a grain of rice into the tip of his penis. The suppository is placed about two inches in the penis is absorbed by erectile tissue increasing the blood flow that causes an erection. Although needles are not used, this method can be painful or uncomfortable, side effects may include pain, minor bleeding in the urethral, dizziness and formation of fibrous tissue.
The treatment of Vacuum devices involves the use of an external vacuum and one or more rubber bands (tension rings). The patient places a hollow plastic tube and pulls blood into the penis. Once he achieves an adequate erection, he slips a tension ring around the base of his penis to maintain the erection. He then removes the vacuum device. The erection typically lasts long enough to have adequate sexual intercourse; he then removes the tension ring after conclusion of the sexual relation.
The vascular surgery treatment method involves surgically placing a device into the two sides of the penis, allowing erection to occur as often and as long as desired. These implants consist of either an inflatable device or semi-rigid rods made from silicon or polyurethane and the use of an inflatable pump, a working fluid, a reservoir capable of holding the fluid and communicating tubes and isolation valves. This treatment is often complicated, expensive and is usually not recommended until other methods have been considered or tried first. As with any surgery, there is a small risk of complications such as infection.
Buuck, in U.S. Pat. No. 3,954,102 describes two expandable cylinders implanted in the penis; replacing the function of the two corpora cavernosa and using working fluid, a reservoir and a transfer pump located in the scrotum to pressurize and transfer the fluid to the expandable cylinders to achieve erection.
Fischell, in U.S. Pat. No. 4,559,931, describes another manually actuated, fluid driven, inflatable penile prosthesis with two cylinders in the coropa caverosa. A diaphragm pump actuator and pressure release chamber are adapted and implanted in the abdomen cavity to be manipulated through the skin of the patient to control the fluid pressure in the system.
Other U.S. patents similar to U.S. Pat. Nos. 4,590,927, 6,723,042, 6,730,017, 6,808,490, they document several implantable penile prosthesis systems, pump devices, valves, connectors and improvements, however they offer mechanical hydraulic driven systems that require to effectively replace the biological function of the corpora cavernosa of the penis.
It is known that penile implants eliminates the possibility of return of natural erections and may require repeated surgery due to infections, erosions, or mechanical problems with the implanted penile device.
The present invention maintains the biological function of the corpa cavernosa for achieving penile erection and keeps the blood flow to and from the penis. The invented penile erectile implant system effectively treats erectile dysfunction due to lack of adequate flow of blood needed for the penis erection. The implant provides means to increase the blood pressure and increase its flow to effect inflation of the corpora cavernosa of the penis. Like that of the normal physiological process, upon achieving orgasm, the blood drains from the penis tissue.
In the present invention as in any human device implant surgeries, risk of blood coagulation is a concern, medical attention and treatment using anti-coagulant drugs may be required to prevent possible blood coagulation problems.